Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

NCT03865290 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 18-005041P01DK068055
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to understand why people with indigestion and diabetes mellitus have gastrointestinal symptoms and in particular to understand whether symptoms are related to increased sensitivity to nutrients in the small intestine. As part of this investigation, a medication called ondansetron will also be studied to determine its effects on gastrointestinal function and associated symptoms.

Conditions

Indigestion; Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• Change in severity of symptoms during enteral infusion

  Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable

  baseline, every 15 minutes up to 8 hours

• Change in severity of symptoms during gastric emptying study

  Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable

  baseline, every 15 minutes up to 2 hours

• Change in severity of daily symptoms

  Gastroparesis Cardinal Symptom Index - Daily Diary (GCSI-DD) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

  Baseline, daily for six weeks

• Change in severity of gastrointestinal symptoms

  Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

  Baseline, 2 weeks, 6 weeks

• Change in severity of gastrointestinal symptoms effect on Quality of Life

  Gastrointestinal Disorders - Quality of Life and Well-Being (PAGI-QOL) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

  Baseline, 2 weeks, 6 weeks

• Change in effect of Gastrointestinal symptoms on Quality of Life

  Nepean Dyspepsia Index used to measure symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

  Baseline

Secondary Outcomes (10)

• Glucose level

  baseline, approximately 60-120 minutes

• Insulin level

  baseline, approximately 60-120 minutes

• C-peptide level

  baseline, approximately 60-120 minutes

• Glucagon-like Peptide 1 (GLP-1)

  baseline, approximately 60-120 minutes

• Cholecystokinin (CCK)

  baseline, approximately 60-120 minutes

Study Arms (6)

Healthy Control Ondansetron 8 mg

EXPERIMENTAL

Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.

Drug: Ondansetron 8mg

Diabetic (DM) gastroenteropathy Ondansetron 8 mg

EXPERIMENTAL

Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. Oral Ondansetron 8 mg administered three times a day for weeks 3-6

Drug: Ondansetron 8mg

Non-ulcer dyspepsia (NUD) Ondansetron 8 mg

EXPERIMENTAL

Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. Oral Ondansetron 8 mg administered three times a day for weeks 3-6

Drug: Ondansetron 8mg

Healthy Control Placebo

PLACEBO COMPARATOR

Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.

Drug: Placebo

Diabetic (DM) gastroenteropathy Placebo

PLACEBO COMPARATOR

Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. Oral matched placebo administered three times a day for weeks 3-6

Drug: Placebo

Non-ulcer dyspepsia (NUD) Placebo

PLACEBO COMPARATOR

Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. Oral matched placebo administered three times a day for weeks 3-6

Drug: Placebo

Interventions

Ondansetron 8mg DRUG

Oral Ondansetron 8 mg

Also known as: Zofran

Diabetic (DM) gastroenteropathy Ondansetron 8 mg; Healthy Control Ondansetron 8 mg; Non-ulcer dyspepsia (NUD) Ondansetron 8 mg

Placebo DRUG

Oral matched placebo

Diabetic (DM) gastroenteropathy Placebo; Healthy Control Placebo; Non-ulcer dyspepsia (NUD) Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or non-pregnant, non-breastfeeding female volunteers;
• years old;
• Able to provide written informed consent before participating in the study
• Able to communicate adequately with the investigator and to comply with the requirements for the entire study; including the willingness and ability to consume the components of the test meals
• Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)
• Patients in the DM group will also require Type 1 or 2 DM of ≥ 3 years duration; in patients with type 2 DM, the dyspepsia symptoms should have begun or worsened after DM was diagnosed

You may not qualify if:

• Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are permissible)
• Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
• Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, and high doses of anticholinergic agents (eg, amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments.
• Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain
• Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies
• Positive tissue transglutaminase antibodies (TTG),
• Pregnant or breast-feeding females
• Known intolerance or allergy to eggs
• Poor peripheral venous access, if central venous access is not available
• Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study
• History of Long QT Syndrome or prolonged QT interval (i.e., corrected QT interval \> 480 ms)
• Current symptoms of a functional gastrointestinal disorder assessed by questionnaire
• Severe vomiting that would preclude tube placement or participation in the study
• Structural cause for symptoms by endoscopy within the past 12 months
• Patients with gastric pacemakers

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Diabetes Mellitus

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Adil E Bharucha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly J Feuerhak

CONTACT

507-255-6802; Feuerhak.Kelly@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 6, 2019
• Study Start: April 2, 2019
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)